PB2067: THE REALM STUDY PROTOCOL: A MULTICENTER, NON-INTERVENTIONAL, RETROSPECTIVE STUDY TO DESCRIBE THE TREATMENT PATHWAYS, OUTCOMES, AND RESOURCE USE IN PATIENTS WITH CD30+ LYMPHOMA FROM CHINA.
Authors: W. Xu, L. Fan, L. Wang, H. Zhu, J. Wang, J. Li
Journal: HemaSphere (2022)

Background: Current scientific evidence on the demography, disease, and distribution characteristics of CD30+ lymphoma subtypes focus on patients from Western Countries. Although some differences have been reported between CD30-expressing lymphoma populations in Western Countries and East Asia, there is limited information on Chinese patients. New targeted therapies such as CD30 monoclonal antibodies have been approved in China for the management of CD30-expressing lymphoma. Analyzing the treatment patterns and outcomes for patients with CD30-expressing lymphoma in a real-world setting will bridge the existing knowledge gap. Aims: Our study aims to investigate the treatment pathways and define CD30-expressing lymphoma patients’ demographic, clinical characteristics, treatment response, survival rate, and healthcare cost and utilization in the Chinese population. Methods: The study represents a multicenter, non-interventional, retrospective study of newly diagnosed or relapsed/refractory CD30-expressing lymphoma patients who received treatment in China between January 1, 2018, and March 31, 2021, with survival follow-up until September 30, 2021. The study will include 1000 patients with classical Hodgkin lymphoma (cHL) and 1100 ~1800 with non-Hodgkin lymphoma (NHL), inclusive of all subtypes, aged ≥ 18 years from 14 hospitals with Haematology or Oncology departments across China. Based on their diagnosis, patients will be assigned to one of the following cohorts: (i) (cHL); (ii) (NHL) with a minimum observation period of 6 months; however, eligible patients who died or were lost to follow-up within 6 months will also be included. The planned study design is shown in Figure 1. The demographic, diagnostic, number of refractory/relapsed, clinical, laboratory parameters, cost, and resources utilized data will be retrieved from hospital information system/electronic medical records/Laboratory information management systems. Clinical characterization will be based on Ann Arbor staging, WHO/EORTC staging of mycosis fungoides/Sézary syndrome, B symptoms, subtype, mass, and ECOG performance status. Patients whose demographics and clinical features are not available from the medical records will be excluded. All data will be analyzed using descriptive statistics. Real-world overall survival (rwOS) and progression-free survival (rwPFS) will be analyzed using Kaplan-Meier estimates at a 95% confidence interval. All statistical procedures will be analyzed using the SAS software, version 9.4. Results: Based on the preliminary analysis of medical records, a total of 2100 to 2800 patients will be included. The study outcomes will be assessed based on subgroups. The study will describe the treatment pathways among adult patients as a primary endpoint. Patient demographics/clinical characteristics, real-world objective response rate, overall survival, progression-free survival, healthcare cost, and resource utilization will be assessed as secondary endpoints. First-line treatment pathways and their related efficacy will be evaluated in newly diagnosed CD30-expressing lymphoma patients in China. Image:Summary/Conclusion: The results of this study may elucidate effective treatment strategies for adult Chinese patients with newly diagnosed or relapsed/refractory CD30-expressing lymphoma. The study will also enable a better understanding of demographic, clinical, pathological characteristics, and the related economic burden of adult Chinese patients with lymphoma.